A Study Of Abenacianine (VGT-309) To Identify Cancer When Undergoing Surgery For Cancer In The Lung

Overview

About this study

The purpose of this study is assess the efficacy of abenacianine with near-infrared (NIR) imaging as an adjunct for lesion visualization and surgical guidance when compared to standard surgical techniques in subjects undergoing surgery for suspected or proven cancer in the lung.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Be willing and able to sign the informed consent and comply with study procedures.

  • Be at least 18 years of age.

  • Be scheduled for or planning to have a surgical resection of a lung lesion or mass with diagnostic and/or curative intent.

  • Meet all requirements for the planned surgery based on opinion of the surgeon, anesthesiologist, and/or other consulting physician.

  • Be able to meet the following conditions:

    • Female participants must be of non-childbearing potential, or,

    • If of childbearing potential, be non-pregnant or non-lactating and agree to use highly effective contraception from screening through Day 30 after treatment.

    • Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days after dosing and agree not to donate semen during this waiting period.

    • Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:

      • Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or

      • Intrauterine device or intrauterine hormone-releasing system

      • NOTE: Participants who abstain from heterosexual intercourse as their usual and preferred lifestyle, will not be required to use contraception as described above. They are required to maintain abstinence from screening through Day 30 after treatment.

      • NOTE: Subjects in a same sex relationship, must use a barrier form of contraception (e.g., condom, diaphragm) to protect against the transfer of the study drug in any bodily fluids.

  • Have not participated in an interventional clinical trial within the last 30 days. (NOTE: participation in a disease registry or quality of life study is not exclusionary).

Exclusion Criteria:

  • They have a known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine.

  • They have received chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to study enrollment. NOTE: Exceptions are those agents used to prevent recurrence of certain cancers, e.g. tamoxifen, letrozole, and anastrozole.

  • They have any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

  • They are prisoners, institutionalized individuals, or are unable to consent for themselves.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/22/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Janani Reisenauer, M.D.

Open for enrollment

Contact information:

Brock Leisen

5072843613

leisen.brock@mayo.edu

More information

Publications

Publications are currently not available